30-day, Open-label, Active-controlled, Randomized Study of the Safety, Efficacy and the Pharmacokinetic and Pharmacodynamic Properties of Oral Rivaroxaban in Children With Various Manifestations of Venous Thrombosis

Rivaroxaban will be provided according to an age- and body weight-adjusted dosing schedule to achieve a similar exposure in children as that observed in adults treated for VTE (venous thromboembolism) with 20 mg rivaroxaban daily. Rivaroxaban will be provided as a tablet for children 12 to 18 years. Once the age-and body weight-adjusted dosing regimen has been finally confirmed for the age group 6 to < 12 years, rivaroxaban will be provided as tablets (and subsequently as oral suspension) for this age group.

Drug: Rivaroxaban (Xarelto, BAY59-7939)

Active Comparator: Standard of care

Children randomized to the comparator group will continue with the anticoagulant treatment that was used prior to study randomization.

Other: Standard of care

Eligibility

Ages Eligible for Study:

6 Years to 17 Years

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Children aged 6 to < 18 years who have been treated for at least 2 months or, in case of catheter-related thrombosis, for at least 6 weeks with LMWH (low molecular weight heparin), fondaparinux and/or VKA (vitamin K antagonist) for documented symptomatic or asymptomatic venous thrombosis and who will enter their last month of intended anticoagulant treatment

Hemoglobin, platelets, creatinine and alanine aminotransferase (ALT) and total bilirubin evaluated within 10 days prior to randomization

Informed consent provided and, if applicable, child assent provided

Exclusion Criteria:

Active bleeding or high risk for bleeding contraindicating anticoagulant therapy

Hepatic disease which is associated with coagulopathy leading to a clinically relevant bleeding risk or ALT > 5x upper level of normal (ULN) or total bilirubin > 2x ULN with direct bilirubin > 20% of the total

Platelet count < 100 x 10^9/L

Hypertension defined as > 95th age percentile

Life expectancy < 3 months

Concomitant use of strong inhibitors of both cytochrome P450 isoenzyme 3A4 (CYP3A4) and P-glycoprotein (P-gp), i.e. all human immunodeficiency virus protease inhibitors and the following azole antimycotics agents: ketoconazole, itraconazole, voriconazole, posaconazole, if used systemically

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Please refer to this study by its ClinicalTrials.gov identifier: NCT01684423